Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 2:16 AM
Ignite Modification Date: 2025-12-25 @ 2:16 AM
NCT ID: NCT01404260
Description: Safety analysis included all patients who received at least one dose of the study drug and had at least one follow-up safety assessment. Safety assessments were analyzed mainly using descriptive statistics.
Frequency Threshold: 1
Time Frame: 4years
Study: NCT01404260
Study Brief: Intercalating and Maintenance Use of Iressa Versus Chemotherapy in Selected Advanced Non Small Cell Lung Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm A Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression None None 14 109 9 109 View
Arm B gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression None None 5 110 1 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View